The field of the invention is drug, bio-affecting and body treating compositions and the invention is particularly concerned with capsules.
The present invention relates to a formed or molded body with an enclosure or envelope of polymer material, gelatine or the like, and with a filling in the enclosure or envelope. Generally, the envelope is a hard or soft gelatine capsule that is filled with pharmaceutical preparations. The invention also relates to a method for manufacturing such formed or molded bodies as well as to a corresponding apparatus suitable for manufacturing the molded bodies and for carrying out the method, respectively.
Reference is made to U.S. Pat. Nos. 1,419,618; 2,155,444 and 4,695,466; British Patent No. 2,099,698; West German Patent Publication No. 1,492,077 and Japanese Published Patent application No. 58/206515 as showing the state of the art which is incorporated herein by reference.
For manufacturing soft gelatine capsules the so-called rotary-die-method has substantially been successful. In this method gelatine bands are guided over forming rollers provided with hollow form recesses or dies and the gelatine bands are introduced between these forming rollers. By means of a filling block in the form of a gore or gusset the gelatine bands are pressed into the mold cavities or dies, and on the other hand at the same time the filling substance is injected into the thus formed capsules. Thus, the soft capsules are manufactured and filled in one working step. Thereby, only one uniform substance or a homogeneous substance mixture, i.e., a mixture of several substances, can be filled into the capsules according to this prior art.
Further, hard gelatine capsules are known which are plugged together telescopically from two prefabricated capsule parts. Prior to the plugging together, in a separate working step or steps a uniform substance, a homogeneous mixture of substances or one after the other different layers of substances or substance mixtures are filled into a capsule main body. The manufacturing of such telescoping capsules is, thus, technically more complicated and more expensive than the manufacturing of soft gelatine capsules. In using several different layers of filling substances for hard gelatine capsules, care must be taken that the substances are compatible with each other and that a mixing or mingling of the substances after the filling is permissible.